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June
8

Comment Deadline: Tissue Agnostic Therapies in Oncology —Regulatory Considerations for Orphan Drug Designation

  • Government
  • Agency
  • Genetics/Genomics

The Food and Drug Administration (FDA) is soliciting public comments to accompany a public workshop titled "Tissue Agnostic Therapies in Oncology —Regulatory Considerations for Orphan Drug Designation." The purpose of the public workshop is to discuss factors FDA should consider when evaluating drugs for orphan designation that treat a tissue agnostic disease or condition in oncology, and additional factors related to orphan exclusivity FDA should consider when approving a product with a tissue agnostic indication.

May
18

Comment Deadline: FDA Patient-Focused Drug Development – Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data

  • Government
  • Agency
  • Genetics/Genomics
  • Neuroscience

The Food and Drug Administration (FDA) is soliciting public comments for the docket titled “Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.” The FDA seeks public input on how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidance to the FDA. These comments will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act (Cures Act).

May
17

Comment Deadline: FDA Early Alzheimer's Disease – Developing Drugs for Treatment (Draft Guidance)

  • Government
  • Agency
  • Industry
  • Neuroscience

The Food and Drug Administration (FDA) is seeking public comment on a draft guidance for industry titled "Early Alzheimer's Disease: Developing Drugs for Treatment." This guidance is intended to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer's disease (AD) that occur before the onset of overt dementia.

May
14

Comment Deadline: Notice of Request for Information (RFI) on Critical Water Issues Prize Competition

  • Government
  • Agency
  • Energy

The U.S. Department of Energy (DOE), Office of Energy Efficiency and Renewable Energy (EERE), seeks information from the public to understand the key technical and other barriers that may prevent long-term access to low-cost water supplies that could be best addressed through challenges and prize competitions.

May
8

Comment Deadline: CPSC Petition Requesting Rulemaking to Exempt Certain Head Protection Devices from the Safety Standard for Bicycle Helmets

  • Government
  • Agency
  • Neuroscience

The US Consumer Product Safety Commission (CPSC) is inviting written comments on a petition received from Hövding Sweden AB. This petition is requesting that the Commission exempt “inflatable head protective devices for bicyclists,” such as Hövding's product, from the testing requirements of the Safety Standard for Bicycle Helmets, if such product complies with, and is certified to, requirements in another standard that Hövding states is appropriate to test such products.

May
7

Comment Deadline: DOT Automation in the Railroad Industry

  • Government
  • Agency
  • Robotics/AI

Federal Railroad Administration (FRA) requests information and comment on the future of automation in the railroad industry. FRA is interested in hearing from industry stakeholders, the public, local and State governments, and any other interested parties on the extent to which they believe railroad operations can (and should) be automated, and the potential benefits, costs, risks, and challenges to achieving such automation.

April
25

Comment Deadline: Interstate and Intrastate Natural Gas Pipelines; Rate Changes Relating to Federal Income Tax Rate

  • Government
  • Agency
  • Energy

The Federal Energy Regulatory Commission is proposing a process that will allow it to determine which jurisdictional natural gas pipelines may be collecting unjust and unreasonable rates.

April
23

Comment Deadline: Notice of Proposed Withdrawal of the Control Techniques Guidelines for the Oil and Natural Gas Industry

  • Government
  • Agency
  • Energy

The Environmental Protection Agency (EPA) is requesting public comment on a potential withdrawal of the Control Techniques Guidelines (CTG) for the Oil and Natural Gas Industry.